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New drug shows promise in reversing lung damage from severe asthma

NCT ID NCT03953300

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 6 times

Summary

This study tests whether benralizumab can improve lung structure and function in people with severe eosinophilic asthma who still have symptoms despite standard treatments. About 75 adults aged 18-70 will receive either the drug or a placebo for 48 weeks, followed by a 4-week check-up. The goal is to see if the drug reduces airway inflammation and prevents long-term lung damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

75 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female aged 18 through 70 years. 2. Physician-diagnosed asthma requiring continuous treatment with medium- or high-dose ICS plus LABA with or without additional controller medication for at least 12 months prior to Visit 1, and current treatment with high-dose ICS plus LABA for at least 3 months prior to Visit 1 with or without additional asthma maintenance medication. 3. Morning pre-BD FEV1 ≥50 to \<80% of predicted normal value (PNV) and ≥1 liter (L) or morning pre-BD FEV1 ≥ 50 to \< 90% of PNV, if historical pre-BD FEV1 value (within 12 months prior to screening visit) was \< 80% of PNV. 4. A blood eosinophil count meeting any of 3 criteria: ≥300 cells/µL during screening or ≥ 220 to \< 300 cells/μL during screening and documented eosinophil count of ≥ 300 cells/μL in the past 12 months, or ≥150 to \<300 cells/µL during screening plus one of the following: presence of nasal polyps or pre-BD FVC \<65% predicted at Visit 2 5. Negative pregnancy test. 6. Asthma control questionnaire (ACQ-6) \>1.5. 7. Fewer than 12 exacerbations within the 6 months prior to Visit 3. Exclusion Criteria: 1. Any disease or concomitant medication which could affect study results or safety of study participants, including: * current smokers * history of cancer * life-threatening asthma * clinically important pulmonary disease other than asthma 2. Use of chronic immunosuppressive medication or receipt of immunoglobulin (or blood products) within 30 days prior to the date informed consent is obtained. 3. Previously received: * benralizumab * live attenuated vaccines 30 days prior to the date of randomization. * bronchial thermoplasty in the last 24 months prior to Visit 1 * any investigational non-biologic within 30 days (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer. * any marketed or investigational biologic for the treatment of asthma within 4 months (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer. 4. Currently pregnant, breastfeeding or lactating women.

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Conditions

The condition(s) this trial relates to.

asthma lung disorder pulmonary eosinophilia T2-high asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • Research Site

    Birmingham, Alabama, 35209, United States

  • Research Site

    Los Angeles, California, 90033, United States

  • Research Site

    Jacksonville, Florida, 32204, United States

  • Research Site

    Miami, Florida, 33166, United States

  • Research Site

    Snellville, Georgia, 30078, United States

  • Research Site

    Indianapolis, Indiana, 46268, United States

  • Research Site

    Iowa City, Iowa, 52242, United States

  • Research Site

    Kansas City, Kansas, 66160, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Bloomfield Hills, Michigan, 48301, United States

  • Research Site

    Rochester, Minnesota, 55905, United States

  • Research Site

    St Louis, Missouri, 63156, United States

  • Research Site

    Maspeth, New York, 11378, United States

  • Research Site

    New Bern, North Carolina, 28562, United States

  • Research Site

    Winston-Salem, North Carolina, 27104, United States

  • Research Site

    Pittsburgh, Pennsylvania, 15213, United States

  • Research Site

    Galveston, Texas, 77555, United States

  • Research Site

    Lewisville, Texas, 75067, United States

  • Research Site

    Mansfield, Texas, 76063, United States

  • Research Site

    Calgary, Alberta, T2N 4Z6, Canada

  • Research Site

    Aalborg, 9000, Denmark

  • Research Site

    Aarhus N, 8200, Denmark

  • Research Site

    Copenhagen, 2400, Denmark

  • Research Site

    Hvidovre, 2650, Denmark

  • Research Site

    Næstved, 4700, Denmark

  • Research Site

    Odense C, 5000, Denmark

  • Research Site

    Vejle, 7100, Denmark

  • Research Site

    Gothenburg, 413 45, Sweden

  • Research Site

    Lund, 22185, Sweden

  • Research Site

    Cambridge, CB2 2QQ, United Kingdom

  • Research Site

    Headington, OX3 9DU, United Kingdom

  • Research Site

    Leicester, LE3 9QP, United Kingdom

  • Research Site

    Liverpool, L7 8XP, United Kingdom

  • Research Site

    London, W1G 8HU, United Kingdom

  • Research Site

    Wythenshawe, M23 9LT, United Kingdom

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